Acne Treatment Gel
FDA Label NDC 76162-229

14 label sections · Submitted to the FDA by Topco Associates Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Acne Treatment (NDC 76162-229). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When Using This Product

  • skin irritation and dryness is more likely to occur if you use aother topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Stop Use And Ask A Doctor If

irritation becomes severe

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor

Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions

1-888-423-0139

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Clean & Clear ®Persa-Gel ®10 Maximum Strength.

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

Itasca, IL 60143 ©TOPCO VIJA0424

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

Quality Guaranteed

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Principal Display Panel

TopCare ®Beauty

ACNE TREATMENT

10% Benzoyl Peroxide

Compare to CLEAN & CLEAR ®Persa-Gel ®10*

Maximum strength benzoyl peroxide acne medication available under the product monograph

This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.

Dermatologist Tested

PARABEN & PHTHALATE FREE

Fragrance Free

NET WT 1 OZ (28 g)

package contains one tube

not actual size

NET WT 1 OZ (28 g)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.